Efficacy evaluation of standardized Rheum rhaponticum root extract (ERr 731®) on symptoms of menopause: A systematic review and meta-analysis study

Menopause is characterized by various physical, mental and emotional symptoms. ERr 731® is a standardized extract from Rheum rhaponticum root and has been clinically studied for its role in reducing menopausal symptoms. The current systematic review and meta-analysis aimed to evaluate the efficacy of ERr 731® supplementation in alleviating the severity of menopausal symptoms. In this review, we searched across three online databases up to March 2023, evaluated the quality of the included studies by the Physiotherapy Evidence Database scale, and assessed the risk of bias by the Cochrane Risk of Bias tool. We then performed a meta-analysis using RevMan software to estimate the pooled mean difference (MD). The study protocol was registered in the Prospective Register of Systematic Reviews (CRD42023416808). After screening and evaluation, we included four high-quality studies (a total of 390 participants; the ERr 731® group: 193 participants; the control group: 197 participants) in the meta-analysis. The results showed that ERr 731® supplementation significantly reduced the Menopause Rating Scale score (MD: –15.12; P < 0.001), compared with control therapy. Sensitivity analysis revealed no effect of individual studies on the overall pooled estimate or overall observed heterogeneity. The current review provides evidence that ERr 731® supplementation is effective in reducing menopause symptoms. Potential bias and high heterogeneity in the results warrant further clinical studies.

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Random allocation
Yes "Women were randomized to either …" Subjects were randomly allocated.

Concealed allocation Yes
"Both participants and investigators and the data monitoring committee were blinded with regard to the individual treatment allocation." Concealment was maintained.
Groups similar at baseline Yes "None of these characteristics, including serum hormone levels, differed significantly between the treatment groups." Groups were similar at baseline.

Subject blinding Yes
"Both participants and investigators and the data monitoring committee were blinded with regard to the individual treatment allocation." Subjects were blinded and the procedures were informed.

Therapist blinding Yes
"Both participants and investigators and the data monitoring committee were blinded with regard to the individual treatment allocation." Therapists were blinded and the procedures were informed.

Assessor blinding Yes
"Both participants and investigators and the data monitoring committee were blinded with regard to the individual treatment allocation." Subjective scales were used, hence assessor was blinded, and procedures were informed.Groups similar at baseline Yes "None of the baseline characteristics differed markedly between the treatment groups …" Groups were similar at baseline.

Subject blinding Yes
"This was a 12-week, multicenter, prospective, randomized, double-blind, parallel-group, placebo-controlled, phase Ⅲ clinical trial …" Subjects were blinded and the procedures were informed.

Therapist blinding Yes
"This was a 12-week, multicenter, prospective, randomized, double-blind, parallel-group, placebo-controlled, phase Ⅲ clinical trial …" Therapists were blinded and the procedures were informed.

Assessor blinding Yes
"This was a 12-week, multicenter, prospective, randomized, double-blind, parallel-group, placebo-controlled, phase Ⅲ clinical trial …" Subjective scales were used, hence assessor was blinded, and procedures were informed.
Less than 15% dropouts Yes As shown in Fig. 1 of study article Data from more than 85% of the subjects initially allocated to groups were obtained for at least one key outcome.
Intention-to-treat analysis Yes "All women in the ERr 731 and the placebo group were included in the intention-to-treat analysis …" Intention-to-treat analysis method was used.

Between-group statistical comparison
Yes Described in detail in study article Between-group statistical analysis was performed, and results are reported.

Point measures and variability
Yes Described in detail in study article Data of point measure and measure of variability for at least one key outcome were reported.

Hasper I et al., 2009
Eligibility criteria specified Yes "Inclusion criteria for the RCT were …" Eligibility criteria were specified.

Random allocation Yes
"A total of 110 women enrolled in the trial were randomized to one of the two treatment groups …" Subjects were randomly allocated.

No Not applicable
No details regarding randomization concealment provided.

Groups similar at baseline
Yes "At baseline (day 0 of the RCT), no remarkable differences in age, height, weight, and BMI, …" Groups were similar at baseline.

Subject blinding Yes
"The initial trial was a 12-week multicenter, prospective, randomized, double-blind, placebocontrolled, phase Ⅲ clinical trial …" Subjects were blinded and the procedures were informed.

Therapist blinding Yes
"The initial trial was a 12-week multicenter, prospective, randomized, double-blind, placebocontrolled, phase Ⅲ clinical trial …" Therapists were blinded and the procedures were informed.

Assessor blinding Yes
"The initial trial was a 12-week multicenter, prospective, randomized, double-blind, placebocontrolled, phase III clinical trial …" Subjective scales were used, hence assessor was blinded, and procedures were informed.

Table 1 Judgement and support for the judgment of each included study in the PEDro scale
Subjective scales were used, hence assessor was blinded, and procedures were informed.Table1of study article Intention-to-treat analysis method was used.